VISCO-3™ Sodium Hyaluronate

VISCO-3Sodium Hyaluronate is a solution made of highly
purified, hyaluronan. You will administer to the patients, a 2.5 mL
injection of VISCO-3 Sodium Hyaluronate once a week for 3 weeks (a
total of 3 injections). One clinical trial revealed patients treated
with VISCO-3 Sodium Hyaluronate had a 52% reduction in their pain at
week 12.1

Indications For Use

VISCO-3 Sodium Hyaluronate is indicated for the treatment of pain
in osteoarthritis (OA) of the knee in patients who have failed to
respond adequately to conservative non-pharmacologic therapy and
simple analgesics, e.g., acetaminophen.

Important Safety Information

Before using VISCO-3 Sodium Hyaluronate, ask your patients if they
are allergic to hyaluronan products, or products from birds such as
feathers, eggs, and poultry. Do not administer to patients with known
hypersensitivity to sodium hyaluronate preparations. Use caution when
injecting VISCO-3 Sodium Hyaluronate into patients who are allergic to
avian proteins, feathers and egg products. VISCO-3 Sodium Hyaluronate
is only for injection into the knee, performed by a doctor or other
qualified health care professional. VISCO-3 Sodium Hyaluronate
injection should not be used in the presence of a skin disease or
infection around the area where the injection will be given. VISCO-3
Sodium Hyaluronate has not been tested to show pain relief in joints
other than the knee and for conditions other than OA. VISCO-3 Sodium
Hyaluronate has not been tested in patients who are pregnant, mothers
who are nursing, or anyone under the age of 21. Strenuous or
pro-longed weight-bearing activities after treatment are not
recommended. The effectiveness of repeat treatment cycles of VISCO-3
Sodium Hyaluronate has not been established. The side effects most
commonly seen after injection of VISCO-3 Sodium Hyaluronate in the
clinical trial were knee pain, swelling, and/or fluid build-up around
the knee. These reactions are generally mild and do not last long.
Other conditions, including but not limited to skin redness and rash,
knee stiffness were also reported. For complete instructions for use,
see the package insert and visit www.zimmerbiomet.com.

This material is intended for US Health Care Professionals.

A double-blind, multi-center, randomized, controlled trial was
conducted in which VISCO-3 Sodium Hyaluronate*was compared to
Euflexxa® 1% Sodium Hyaluronate (NCT 02110238). The study
enrolled a total of 421 subjects.1

Safety2

Safety analysis included all subjects who received at least one
injection (n = 211 Euflexxa, n = 209 VISCO-3). There was no
significant difference in the total Treatment-Emergent Adverse Events
(TEAEs) with VISCO-3 Sodium Hyaluronate compared to Euflexxa (Table
1). A total of seven serious adverse events (SAE) were reported,
however none were considered to be related to the study devices. There
were no reports of pseudoseptic events or allergic reactions in the
study. The most common device related adverse events in the VISCO-3
group were arthralgia (1%), joint swelling (1.4%) and injection site
pain (1%).

Table 1: Overall Summary of Treatment-Emergent Adverse Events (TEAEs)

Category

Euflexxa (N=211) n(%)

VISCO-3 (N=209) n(%)

Subjects with ≥ 1 TEAE

109 (51.7)

107 (51.2)

Subjects with ≥ 1 TEAE related to
study device

14
(6.6)

9 (4.3)

Subjects with ≥ 1 serious adverse
event (SAE)

6
(2.8)

1 (0.5)

Effectiveness2

The analysis of effectiveness was based on the 384 evaluable
patients over the 12 week time point. The effectiveness of the
treatments was measured as WOMAC VAS pain subscale change from base
line (CFB). The Key effectiveness outcomes are presented below (Table
2). The mean baseline WOMAC VAS pain subscale was 57.83 in the VISCO-3
Sodium Hyaluronate group and 58.40 in the Euflexxa Sodium Hyaluronate
group. The least squares mean for CFB for VISCO-3 Sodium Hyaluronate
minus that of the control gives a WOMAC VAS subcale sore of -3.30 mm.

VISCO-3 Sodium Hyaluronate demonstrated noninferior pain relief
compared to patients treated with Euflexxa Sodium Hylauronate. This is
concluded based upon the fact that the lower bound of the 95% CI
(-6.77 mm) is greater than -8 mm. On average, patients treated with
VISCO-3 Sodium Hyaluronate saw a 52% reduction in pain at week 12
compared to baseline.

Post Market Experience2

Literature has shown that repeated treatment cycles of the VISCO-3
Sodium Hyaluronate formulation contain no evidence of an increased
safety risk. The frequency and severity of adverse events occurring
during repeat treatment cycles did not increase over that reported for
a single treatment cycle.

Strict aseptic administration technique must be followed. Apply
antiseptic to the skin and, if desired, local subcutaneous anesthetic
such as lidocaine may be injected prior to injection with VISCO-3
Sodium Hyaluronate. Do not use disinfectants containing quaternary
ammonium salts for skin preparation.

The knee joint may be accessed through the soft palpable
anterolateral port, located just lateral to the inferior pole of the
patella and the proximal portion of the patella tendon (Figure 1) or
other approach per physician preference.

Peel off the lid from the VISCO-3 Sodium Hyaluronate blister package
and remove the syringe. Carefully remove the tip cap of the VISCO-3
Sodium Hyaluronate syringe. Aseptically attach the VISCO-3 Sodium
Hyaluronate syringe to a sterile 22-23 gauge needle.

Inject the full 2.5 mL of VISCO-3 Sodium Hyaluronate into the knee
joint using aseptic injection technique (Figures 3-4). If
administering treatment to both knees, use a separate syringe of
VISCO-3 Sodium Hyaluronate for each knee.

Administer the subsequent two intra-articular injections one week
apart, for a total of three injections 1 week apart for 3 weeks.

Information and material about reimbursement is informational only.
Changes in reimbursement laws, regulations, and policies may occur
without notice. Providers should report the procedure and related
codes that most accurately describe the particular patient’s medical
condition, procedures performed, and products used based on the
provider’s experience and Medicare rules and guidelines and other
payer requirements. Zimmer Biomet specifically disclaims liability or
responsibility for the results or consequences of any actions taken in
reliance on information and material about reimbursement.

VISCO-3™ and Supartz® are trademarks of Seikagaku
Corporation. Euflexxa® is a trademark of
Ferring B.V. LLC.

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intellectual property rights, as applicable, owned by or licensed to
Zimmer Biomet or its affiliates unless otherwise indicated, and must
not be redistributed, duplicated or disclosed, in whole or in part,
without the express written consent of Zimmer Biomet.

This material is intended for health care professionals.
Distribution to any other recipient is prohibited.

For product information, including indications, contraindications,
warnings, precautions, potential adverse effects and patient
counseling information, see the package insert and information on this
website. To obtain a copy of the current Instructions for Use (IFU)
for full prescribing and risk information, please call 1-800-348-2759,
press 4 for 411 Technical Support.

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